Author Topic: Patient organizations letter to HHHS  (Read 1122 times)

Patricia/Wildaisy

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Patient organizations letter to HHHS
« on: May 17, 2013, 03:52:41 AM »
A forum member sent me this information in a private message and asked my opinion.  I prefer to answer to the forum.   My answer appears in the second post in this thread.

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On May 12, a group of patient organizations and advocates sent a letter sent to Secretary Sebelius, Dr. Frieden, Dr. Collins and Dr. Koh calling for the adoption of the Canadian Consensus Criteria and for stopping the use of overly broad and non-specific "CFS" definitions and the medical education material associated with them. The group has taken this position because we can not make forward progress as long as this issue is not resolved. 



Currently, the CDC states that CFS can be defined by any of 5 different "CFS" definitions. Three of these require the hallmark symptoms of ME but the two most commonly used, Fukuda and Oxford, do not require hallmark symptoms, allow primary psychiatric illness and in the case of Oxford only requires one symptom – 6 months of disabling fatigue. This has created tremendous confusion on the nature of ME by associating it with depression, deconditioning, excessive rest, maladaptive coping styles, false illness beliefs and a catchall for any unexplained chronic fatigue. This confusion has confounded research with conflicting results, stalled drug development and negatively impacted clinical care. Patients have paid dearly with harmful recommendations, stigma, disbelief – and decades with no treatments and little hope.



The patients that we all saw at the FDA stakeholder meeting do not suffer from deconditioning, false illness beliefs or maladaptive coping. They suffer from a devastating disease that has stolen their lives and left them at the mercy of bodies that punish them for even minimal levels of activity. We are calling for DHHS to:


1. Adopt a disease-appropriate case definition for ME now, utilizing the Canadian Consensus Criteria (as recommended by DHHS’ own advisory committee CFSAC) as the baseline definition that can be further evolved. Train doctors with appropriate medical guidance.

2. Stop using the terms “CFS” and “Chronic Fatigue Syndrome” along with the non-specific definitions like Fukuda and Oxford and the medical education material based on these definitions.

3. Manage the adoption of the Canadian Consensus Criteria to ensure that insurance and disability do not lapse and that no patients fall through the cracks.

4. Fully engage ME stakeholders in the planning and execution of the adoption of the Canadian Consensus Criteria. 

The full letter/position paper can be found here: http://bit.ly/YDPnmJ

Additional background on the letter can be found here: http://bit.ly/10OLy0g 
« Last Edit: May 17, 2013, 04:25:03 AM by Wildaisy »
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Patricia/Wildaisy

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Re: Patient organizations letter to HHHS
« Reply #1 on: May 17, 2013, 04:01:23 AM »
 My opinion of the May 12, 2013 letter from "patient" organizations and "independent advocates" to HHHS.

 I agree with this:

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Of all the issues that we face today, the one issue that has created the most problems is the diverse case definitions associated with our disease. This single issue has severely impacted research, drug development and clinical care and misled the medical community on the very nature of this devastating disease, causing many doctors to not believe that their patients are really sick. Until this issue is addressed, patients will continue to pay the price. This must stop now.
 
 Today, the CDC states that there are at least 5 different definitions for “CFS”. Three of these definitions - the Canadian Consensus Criteria, the ME International Consensus Criteria and the Pediatric Criteria - require hallmark criteria like PEM/PENE and neurological, immunological and energy production impairments. Unfortunately, two of the most commonly used definitions, Fukuda and Oxford, do not require these hallmark criteria. In fact, Oxford only requires 6 months of disabling fatigue - no other symptom - and allows primary psychiatric disorder.
 
 The result? Myalgic encephalomyelitis, the disease seen in outbreaks throughout the twentieth century and recognized by the World Health Organization in 1969, has disappeared, and in its place we are left with “CFS”, an amorphous umbrella of unrelated fatiguing conditions including, according to the literature, depression, deconditioning, medically unexplained chronic fatigue, and for some researchers and clinicians, fatigue due to “excessive rest” or “false illness beliefs”. In clinical practice, the diagnosis of CFS is given to a heterogeneous mix of patients – those with ME, those with the varied fatiguing conditions listed above, and those who were misdiagnosed or whose doctors use the diagnosis of CFS as a catch-all for unexplained fatigue. And in 2012, an American Family Physician article proclaimed that Oxford and Fukuda are the appropriate definitions for “CFS” and further stated: “[CFS] patients with poor social adjustment, a strong belief in an organic cause for fatigue, or some sort of sickness benefit (i.e., financial incentive) tend to have worse responses to [cognitive behavioral] therapy.”
 
 Exactly what disease are we talking about here?
 
 Patients have paid dearly for the proliferation of these overly broad and non-specific definitions – bedbound or homebound, unable to work or take care of their families, suffering for 10, 20, 30 or more years from the myriad symptoms that plague their bodies, unable to get adequate medical care and ultimately more likely to die prematurely from cancer, cardiovascular disease and suicide.
 
 As Dr. Carruthers stated in the ME International Consensus Criteria, “Research on other fatiguing illnesses, such as cancer and multiple sclerosis, is done on patients who have those diseases. There is a current, urgent need for ME research using patients who actually have ME.” We must have a disease appropriate definition for ME that is separate and distinct from all the other unrelated conditions encompassed by the overly broad, fatigue-focused “CFS” definitions.

 
Where I differ from this group of so-called advocacy organizations and “independent advocates” is in what needs to be done.
 
For far too long, we, as M.E. patients, have allowed our “advocates” to persuade us to compromise. They tell us this is the way toward progress; but what progress has been made in the last 30 years of compromises.  Do we know the cause of M.E.?  Are we respected by medical professionals?  Is real research being done to ascertain the etiology of the disease?  Do we have effective treatments?
 
The answer to all of these questions is “NO.”
 
I agree that the first thing we need is a solid definition of the disease, and that definition must clearly delineate the differences between M.E. and the symptom of “chronic fatigue” which is a symptom of many different diseases, as well as depression.  We suffer from a real biological disease and not a disease of the mind.  We need real biological treatments and not behavior therapy or exercise.  We need for this very real disease which devastates our lives to be recognized as such by medical professionals and government researchers. 
 
This will not be accomplished by half measures.  We have tried for 30 years to be practical and reasonable and accepted the compromises promulgated by our so-called “advocacy organizations” who said these were just accommodations to use in transition. 

The problem is, when we have accepted those half measures in the past, those organizations have taken those compromises and stopped.  How much good has it done us that the CFSAC recommended the use of the term “CFS/ME.” 

In my opinion, this usage has done more harm than good because it gives evidence for those who propose “CFS/ME” as a psychological illness (“false illness beliefs’) that there is too much confusion about what the disease really is.  I believe it encourages the overly broad definition favored by the CFIDS Assn of America and the CDC which includes people who are tired and/or depressed.
 
Every one of us who suffers from M.E. knows exactly what this disease is.  It is a physical illness which has ruined our lives and stolen what we most valued, including our professions, our social and family relationships and even our identities. 

Will it really help to compromise again?  I don’t think so.
 
What have our past compromises accomplished?  Do we know the cause of M.E.?  Are we respected by medical professionals?  Do we receive effective treatments?  The answer to all these question is a “NO!”
 
This letter does not even suggest starting with a real definition of the disease.  It suggests using the IACFS Primer as a transition to the Canadian Consensus Definition.

This IACFS Primer says (Page 21):

http://www.iacfsme.org/Portals/0/PDF/PrimerFinal3.pdf  )
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Exercise Recommendations.  An individualized activity plan should be developed in collaboration with the patient.  72,73  Consultation with rehabilitation professionals knowledgeable about ME/CFS may also be desirable.  Any exercise or activity program should seek to minimize the negative effects of exertion on impaired aerobic function.

 Exercise should also not take priority over activities of daily living.
 
Initially, the patient’s degree of activity limitation can be estimated using a functional status rating such as the Functional Capacity Scale (Appendix C).  This 10 point scale ranges from 10, for symptom-ree individuals  scale ranges from 10, for symptom-ree individuals  scale ranges from 10, for symptom free individuals, to 1, for patients who are bedridden and unable to perform activities of daily living.
 
Severely ill patients (functional capacity rating 1-3; Appendix C).  Homebound and bedbound patients may benefit from in-home services that provide assisted range-of-motion and strengthening exercises.  Exercise lying down should be avised when exercise standing or sitting is poorly tolerated.  Initially, interval training exercise should begin with gentle stretching to improve mobility utilizing intervals of 90 seconds or less.  The patient should rest between intervals until complete recovery has occurred.  Additional intervals can be added when the stretching exercises do not trigger post-exertional symptoms.  Then, resistance training can begin (functional capacity rating 4-5) with elastic bands or light weights.  As endurance improves, short-duration interval training such as leisurely–paced walking, swimming, or peddling on an exercise cycle.  74  The initial duration may vary from 5-15 minutes a day depending on how much the patient can do without provoking symptom flares.  These higher functioning patients may also benefit from adaptive yoga and Tai Chi.

 
The IACFS Primer also recommends Cognitive Behavioral Therapy (CBT).  See page 23

http://www.iacfsme.org/Portals/0/PDF/PrimerFinal3.pdf   )

 
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5:7 Cognitive Behavioral Therapy (CBT)

CBT is a much publicized and debated psychotherapeutic intervention for ME/CFS that addresses the interactions between thinking, feeling and behavior.  It focuses on current problems and follows a structured style of intervention that usually includes a graded activity program.  CBT may improve coping strategies and/or assist in rehabilitation, but the premise that cognitive therapy (e.g., changing “illness beliefs”) and graded activity can “reverse,” or cure the illness is not supported by post-intervention outcome data.  78, 79 


 
I object strenuously to any statement that CBT and GET are going to help people with M.E.  That description of G.E.T. described in the Primer would be a recipe for disaster for someone who suffers from severe M.E. like me. 

The idea as described is that if exercise doesn’t make you crash, then you should add more.  In this way, exercise could succeed in making the patient worse for an indefinite period of time.   

Before I learned better, I did engage in a form of such exercise, and I firmly believe that the harm from that is part of the reason I am so devastatingly ill today.
 
I do not endorse the use of the IACFS Primer or the Canadian Case Definition.  The fact that the Canadian Case definition has been used by a few researchers in the past is not a recommendation that it be used in the future.  Now that we have a better definition, we should use the better definition.  We will not find a bright future by going backward.
 
I recommend the use of the International Consensus Criteria
(   See:  http://niceguidelines.files.wordpress.com/2011/07/myalgic-encephalomyelitis-international-consensus-criteria.pdf   )
  (from the Abstract):]

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 The label “chronic fatigue syndrome” (CFS) has persisted for many years because of lack of knowledge of the etiological agents and of the disease process. In view of more recent research and cinical experience that strongly point to widespread inflammation and multisystemic neuropathology, it is more appropriate and correct to use the term “myalgic encephalomyelitis” (ME) because it indicates an underlying pathophysiology.  It is also consistent with the neurological classification of ME in the World Health Organization’s International Classification of Diseases (ICD G93.3).  Consequently, an International Consensus panel consisting of clinicians, researchers teaching faculty and an independent patient advocate was formed with the purpose of developing criteria based on current knowledge.  Thirteen countries and a wide range of specialties were represented.  Collectively members have approximately 400 years of both clinical and teaching experiencing, authored hundreds of peer reviewed publications, diagnosed or treated approximately 50,000 ME patients, and several members coauthored  previous criteria. 

 

If the CCC is used, a patient could not be diagnosed with “ME/CFS” until 6 months has elapsed.  This is a great disadvantage because it requires not only that the patient suffer six months of pain and disabling symptoms, but it puts that patient at a disadvantage in the use of many treatments.  The ICC does not require this 6-month waiting period.

The use of fatigue in the name of the illness is a severe disadvantage:

Quote

 (ICC)
Using “fatigue” as a name of a disease gives it exclusive emphasis and has been the most confusing and misused criterion.  No other fatiguing disease has “chronic fatigue” attached to its name—e.g. cancer/chronic fatigue, multiple sclerosis/chronic fatigue—except ME/CFS.  Fatigue in other conditions is usually proportional to effort or duration with a quick recovery, and will recur to the same extent with the same effort or duration that same or next day.  The pathological low threshold of fatigability of ME describe in the following citeria often occurs with minimal physical or mental exertion, and with reduced ability to undertake the saem activity within the same or several days.
 
The International Consensus Criteria (Table 1) identify the unique and distinct characteristic patterns of symptom clusters of ME.  The broad spectrum of symptoms alerts medical practitionersto areas of pathology and may identify critical symptoms more accurately [18-20].  Operational notefollowing each criterion provide guidance in symptom expression and contextual interpretation.  This will assist the primary clinician in identifying and treating ME patients in the primary care setting.

Criteria Are Supported by Research

Criterial symptoms are supported by a study of more than 2,500 patient that determined which symptoms had the greatest efficacy to identify ME patients [22].  Investigations of gene epression [23-27] and structure further support the criteria at a molecular level incuding anomalies of increased oxidative stress [4, 28], altered immune and adrenergic signaling [29,340], and altered oestrogen receptor expression [31].  In addition, evidence supporting a genetic predisposition to ME points to modifications in serotonin transporter genes [32, 33], the glucocorticoid receptor gene [34], as wel as HLA claws II involvement [35).  The potential combinatorial effects of these modifications have receive limited attention [36, 37].  Some early broad based studies show a lack of objective findings such as no association with HLA genotype [38].  A study of patients from a twin registry suggested that environmental factors may outweigh any genetic predisposition inn broad based patient populations [39].
 
        Underlying problems of inconsistent findings in research studies have been identified [40, 41] and include a need for studies to be based on larger sample sizes with a more clearly defined phenotype; in particular one that recognizes the likely existence of significant subgroups within the patient population.  In a study of the Reeves empirical criteria [16], Jason et al [18] reported that thirty-eight percent (8%) of patients diagnosed with Major Depressive Disorer were misclassifie s hving CFS and only ten percent (10%) of patients identified as having CFS actually had Me.  Accordingly, the goal of this consensus report is to establish a more selective set of clinical criteria that would identify patient who have neuroimmune exhaustion with a pathological low-threshold of fatigability and symptom flare in response to exertion.  This will enable like patients to be diagnosed and enrolled in research studies internationally under a case definition that is acceptable to physicians and researchers around the world.


 
There is no question that the International Consensus Criteria is more precise and more clearly stated.  It is also supported by research.  It is accurate.  The Canadian Consensus Criteria is a confused statement which includes even more confusing descriptions of symptoms.

 
Why should patients go to the trouble of requesting change from government officials if they are not going to request the change we really need?
 
We need the ICC because it is accurate, while the CCC is not.  We will not go forward into the future by clinging to the past.   If we are going to seek change, let us seek the change we really need, not another compromise. 

Why should we, as patients, spend our precious energy in pursuit of goals which are not what we really need and want?  We need the International Consensus Criteria, not the Canadian Consensus Definition and its partner, the IACFS Primer.
« Last Edit: May 17, 2013, 10:47:56 PM by Wildaisy »
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geraldt52

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Re: Patient organizations letter to HHHS
« Reply #2 on: May 17, 2013, 04:19:55 PM »
Wildaisy, in your last paragraph you said this: "There is no question that the International Consensus Definition is more precise and more clearly stated.  It is also supported by research.  It is accurate.  The ICC is a confused statement which includes even more confusing descriptions of symptoms."

Based on the rest of your post, I think that you meant to say "...The CCC is a confused statement...".  Am I misreading your position (entirely possible)?   

Patricia/Wildaisy

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Re: Patient organizations letter to HHHS
« Reply #3 on: May 17, 2013, 10:48:56 PM »
Thank you, Gerald.  I made the correction.

What do other forum members think about this issue?
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floydguy

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Re: Patient organizations letter to HHHS
« Reply #4 on: May 17, 2013, 11:24:08 PM »
Thank you, Gerald.  I made the correction.

What do other forum members think about this issue?

I have stated it many times but I think it's really the only issue at the moment.  Generally I think the ICC is okay but I'd like to see objective proof that certain things exist.  "PEM" could just be a check off box with the statement "Do any of your symptoms get worse after exercise"?  I also find it overly complex and still too many holes in it.  However, it is far better than Fukuda so at least it's directionally correct.

Patricia/Wildaisy

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Re: Patient organizations letter to HHHS
« Reply #5 on: May 26, 2013, 05:40:18 PM »
Quote
Contrary to widespread misinformation, the Canadian ME/CFS definition is not an ME definition. It was published a decade ago in a journal that no longer exists. The authors of the Canadian ME/CFS definition have abandoned it in favor of the ME-ICC.
 
 The ME-ICC were written by an independent group of doctors and scientists, who, collectively, have 400 combined years of clinical and research experience, and have diagnosed or treated approximately 50 thousand patients.
 
 The ME-ICC specifically rejects labeling ME as CFS or ME/CFS, and clearly spells out that the objective is to split ME from CFS. They aren’t talking about subgroups, but DISTINCT separation.
   
 This was based on scientific consensus using the delphi process, not personal preferences or political consensus based on beliefs or opinions of a narrow group, which currently seems to be the case.

Jill Mclaughlin CFSAC Testimony - May 23, 2013
http://www.mecfsforums.com/index.php/topic,16061.msg150766.html#new
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mclaughlinjill

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Re: Patient organizations letter to HHHS
« Reply #6 on: May 26, 2013, 08:35:43 PM »
Thank you WD, agree completely. Who wrote this HHS letter? It is a non-sequitor. Honestly is it deliberate to throw patients off track? Perhaps why they continue to branch out like crazy, like this latest "NAAME" group. Latest is to not identify who is involved. All as groups and advocates. Who is it really, but ALL the same suspects are quoted or included or listed as resource.

Patricia/Wildaisy

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Re: Patient organizations letter to HHHS
« Reply #7 on: June 11, 2013, 06:23:50 AM »
Elizabeth Unger's Reply
 
 Elizabeth Unger (Chief of the Chronic Viral Diseases Branch at the CDC) has now replied to the letter as follows:
 
 Sent: Wednesday, June 5, 2013 5:58 PM

Subject: Response to signatories of May 12 letter c/o Marry Dimmock

 Dear Patient Organizations and Independent Patient Advocates:

 Thank you for your letter to Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention (CDC), stating your concerns about the Department of Health and Human Services (DHHS) activities related to the definition of Chronic Fatigue Syndrome (CFS), as well as your suggested steps to improve research and treatment. Your email was forwarded to me as Chief of the Chronic Viral Diseases Branch that studies CFS at CDC.

 I can assure you that CDC is aware of the issues you have described and recognizes that patient advocates are essential partners in moving forward. CDC is fully committed to working with the CFS Advisory Committee (CFSAC) and DHHS to develop consensus about the case definition and name of this devastating illness. The need is not only for a case definition but also for reproducible standardized approaches to applying it, as well as for biomarkers to refine subgroups within the overall CFS patient population.

 We are encouraged by the increasing engagement of NIH, FDA, HRSA, and AHRQ through the forum provided by CFSAC. The NIH’s State of the Knowledge Workshop on Myalgic Encephalomyelitis (ME)/CFS Research and AHRQ’s Systematic Review of the Current Literature Related to Disability and CFS are essential steps towards our shared goal of improving care for CFS patients. Likewise, the FDA’s Workshop on Drug Development for CFS and ME has provided new opportunities to capitalize on the energy and collaborative spirit of federal partners and stakeholders. CDC remains dedicated to conducting public health research, developing educational initiatives, and validating CFS phenotypes by utilizing the clinical expertise of physicians experienced in the care and treatment of CFS patients. CDC will continue to engage CFSAC, public health partners, and patient advocates in the development of control and prevention strategies to reduce the morbidity associated with CFS and to improve the quality of life of persons with CFS and other similar medically unexplained chronically fatiguing illnesses such as ME, fibromyalgia syndrome, neurasthenia, multiple chemical sensitivities, and chronic mononucleosis.

 Sincerely,
 Beth Unger
 
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Patricia/Wildaisy

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Re: Patient organizations letter to HHHS
« Reply #8 on: June 11, 2013, 06:32:07 AM »
Obviously, the CDC are not going to pay the slightest bit of attention to this NAAME group.

Hey, I have a radical idea.  Maybe we should ask actual PATIENTS what definition they think is best and what primer they think is best.  If Mary Dimmock had asked patients what they thought before she asked the CDC for what she wanted rather than what patients want most, she might not have alienated so many people.

But change from one bad definition to another, or one that is a little bit better but has major problems, is just not worth sick patients pushing themselves.
« Last Edit: June 11, 2013, 10:41:55 AM by Wildaisy »
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Ember

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Re: Patient organizations letter to HHHS
« Reply #9 on: June 15, 2013, 06:36:10 AM »
I prefer the goals set out by NAME-us.org: http://name-us.org/Goals.htm

Patricia/Wildaisy

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Re: Patient organizations letter to HHHS
« Reply #10 on: June 15, 2013, 10:06:26 AM »
I agree with you, Ember.  In case anyone has forgotten what they are:


http://name-us.org/Goals.htm

Quote
Our Goals
1.  To increase awareness of the urgent need for formal recognition of M.E. as a disabling neuroimmune disease afflicting nearly a million people in the U.S. and 17 million people worldwide, based on over two decades of solid research and over 70 years of clinical observations, and has a World Health Organization (WHO) listing in the neurological chapter of  the International Classification of Diseases (ICD) since 1969.

 2.  [*Goal met July 2011!]  To increase awareness of the need for a research definition based on hard evidence of multiple body system abnormalities, not on degrees or variations of "fatigue," or a within broad category of fatiguing  and psychological illnesses.

 3.  [Updated July 2011] To advocate for the implementation of the Myalgic Encephalomyelitis: International Consensus Criteria and The Nightingale Definition of Myalgic Encephalomyelitis (M.E.)not only here in the U.S, but worldwide, to make these valuable documents available to all health care professionals, and to support their operationalizing to an international research definition.

 4.  Through the above actions, bring the internationally used and correct term, M.E., into common usage and familiarity in every medical establishment and household in the U.S.  This disease needs to be distinguished from cfs, for the benefit of both M.E. patients and those diagnosed with cfs that do not fit M.E. definitions.  Some treatments for cfs can be seriously harmful for those with clearly defined M.E., and some cfs patients are prematurely (mis)diagnosed without thorough screening for M.E. or other serious but treatable illnesses, and everyone in this country and abroad - medical practitioners and general public alike - needs to be aware of these facts.
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Ember

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Re: Patient organizations letter to HHHS
« Reply #11 on: June 15, 2013, 07:55:14 PM »
“The National Alliance for Myalgic Encephalomyelitis website is produced and maintained by severely ill patients with a desire to clearly delineate this neuroimmune disease, Myalgic Encephalomyelitis, in working toward the goal of finding proper treatments and eventually a cure.” 

How can we support these patients and their goals?